MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC SV (SMALL VEINS), 3CG; PERIPHERALLY INSERTED CENTRAL CATHETER (PICC)

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The manufacturer has received the sample and will be evaluated.A supplemental will be submitted with evaluation results.
Event or Problem Description
It was reported, kinked picc.Catheter placed (b)(6)2024 in brachial vein.Catheter length: 34cm, 3cm exit site markings.Statlock used.Kink noted at 12cm mark.General location: axillary region.Catheter pulled back.No other information was provided.
Additional Manufacturer Narrative
H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The complaint of kinked catheters was confirmed but the cause is unknown.Two radiographic images for two different events were returned for evaluation: one for the event on (b)(6) 2024 (auto id # 11) and one for the event on (b)(6) 2024 (auto id # 12).One of the radiographs (auto id #11) was a coned down view of the right chest containing a right-sided placed picc.The catheter appeared to be looped in the distal subclavian vein extending into the right internal jugular vein.The tubing may have been kinked as a result of the looped tubing.The tubing tip was seen overlaying the right ij.The exact cause of the looping of the catheter could not be determined from the image.It is possible that anatomical variables may have been a contributing factor; the svc confluence can be difficult for the catheter to traverse due to scarring, valves, and/or external or internal anatomic problems.The other radiograph (auto id #12) was a coned down frontal view of the right axilla and right chest.There was a right-sided placed picc present.The catheter shaft appeared to be kinked in the axilla.Possible contributing factors for kinks in this location could include anatomical variables such as valves, the angle of the vein confluence, and transitions between the axilla and the thoracic cavity.The arm pit can also become a pinch point depending upon positioning.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: POWERPICC SV (SMALL VEINS), 3CG
• Common Device Name: PERIPHERALLY INSERTED CENTRAL CATHETER (PICC)
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: maddy vincent ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 21317095
• Report Number: 3006260740-2025-00363
• Device Sequence Number: 8435123
• Product Code: LJS
• UDI-Device Identifier: 00801741087110
• UDI-Public: (01)00801741087110(11)240621(17)250930(10)REJS4678
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2025
• Device Model Number: N/A
• Device Catalogue Number: 1274108D
• Device Lot Number: REJS4678
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2025
• Supplement Date Received by Manufacturer: 03/24/2025
• Initial Report FDA Received Date: 02/05/2025
• Supplement Report FDA Received Date: 04/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown